ISO 15002:2023 医療ガス供給システムに接続するための流量制御装置 | ページ 2

1.1この文書は、ユーザーが直接、プローブまたはガス専用コネクタを使用して、または ISO 5359 に準拠した低圧ホース アセンブリを使用して間接的に接続できる流量制御装置の要件を指定します。

• a) ISO 7396-1:2016 に準拠した医療ガスパイプラインシステムの ISO 9170-1 に準拠した端末ユニット。
• b) ISO 10524-1:2018 に準拠したレギュレーターの圧力出口。または
• c) ISO 10524-3 に準拠したバルブ一体型圧力調整器 (VIPR) の圧力出口に接続します (5.2 ガス入口を参照)

1.2この文書は、次のタイプのフロー制御デバイス(FCD) に適用されます。

• a)流量計;
• b)流量計 FCD ;他の
• c)固定オリフィス FCD 。

1.3この文書は、以下のガスの流量制御装置に適用されます。

• 酸素;
• 酸素93%。
• 亜酸化窒素;
• 医療用空気。
• 二酸化炭素;
• 酸素/亜酸化窒素混合物 50/50 (体積分率%);
• 酸素が豊富な空気。
• ヘリウム;
• キセノン;他の
• 上記のガスの指定された混合物。

1.4この文書は、次のようなフロー制御デバイスには適用されません。

• a)手術器具を駆動するためのガスとともに使用するため。
• b)レギュレーターの不可欠な部分 (ISO 10524-1:2018 を参照)または
• c)統合圧力調整器 (VIPR) を備えたバルブの一体部分 (ISO 10524-3 を参照)

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO document should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives ).

ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents . ISO shall not be held responsible for identifying any or all such patent rights.

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html .

This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas supply systems.

This third edition cancels and replaces the second edition (ISO 15002:2008), which has been technically revised. It also incorporates the Amendment ISO 15002:2008/Amd.1:2018.

The main changes are as follows:

• title changed as the requirements for flow control devices are the same regardless of the gas supply and they control the flow, they do not measure the flow;
• layout changed from requirements for each type of flow control device to the common requirements as they are the same for each flow control device;
• test methods have been rationalised and put into a new Annex C;
• hazard identification list added as a new Annex D;
• the maximum flow that can be achieved when the flow control is opened fully has been included as a marking requirement on the device so that the user will know what could be delivered to the patient. A rationale has also been added to cover this marking requirement;
• a new requirement has been added for stability of setting;
• the environmental conditions have been aligned with IEC 60601-1-12, emergency equipment, as flow control devices are used in such environments; and
• the requirement for accuracy has been rationalised for clarity.

Introduction

Flow control devices are used to administer a prescribed flow of gas to a patient interface device (e.g. nasal cannula, facemask) from a pressure gas source, such as a medical gas supply system. These devices need to deliver accurate flows under varying conditions of temperature and inlet pressures. Therefore, it is important that the performance characteristics be specified and tested in a defined manner.

Annex A provides additional insight into the reasoning that led to the requirements and recommendations that have been incorporated in this document. It is considered that knowledge of the reasons for the requirements will not only facilitate the proper application of this document but will expedite any subsequent revisions.

1 Scope

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

Bibliography